Cagrilintide

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 15 of 105 publications on PubMed
Registered clinical trials 44 18 active
Adverse event reports 4 3 classified as serious
  • Cagrilintide is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 105 publications mentioning it, including 15 randomized controlled trials and 6 animal-only studies.
  • ClinicalTrials.gov lists 44 registered studies testing it (18 active).
  • FDA's adverse event system (FAERS) holds 4 reports mentioning it; 3 classified as serious. Reports do not prove causation.

Research topics

  • Obesity 49
  • Semaglutide 35
  • Islet Amyloid Polypeptide 34
  • Weight Loss 34
  • Diabetes Mellitus, Type 2 26
  • Glucagon-Like Peptides 24
  • Anti-Obesity Agents 23
  • Hypoglycemic Agents 23
  • Glucagon-Like Peptide-1 Receptor Agonists 22
  • Glucagon-Like Peptide 1 14

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 105
  • Human (MeSH) 64
  • Animal only 6
  • Clinical trials 15
  • Randomized controlled trials 15
  • Systematic reviews & meta-analyses 11
  • Case reports 0
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
44
Active
18
With posted results
1

Conditions studied

  • Obesity 26
  • Overweight 13
  • Diabetes Mellitus, Type 2 7
  • Type 2 Diabetes 6
  • Type 2 Diabetes Mellitus 2
  • Obesity or Overweight 2
  • Obese 1
  • Cardiovascular Disease 1
  • Diabetic Peripheral Neuropathy 1
  • Alcohol-related Liver Disease 1
  • Chronic Kidney Disease 1
  • Hepatic Impairment 1
Study Status Phase Start
Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
NCT07817251 Novo Nordisk A/S
Recruiting Phase 3 September 16, 2026
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
NCT07282613 Novo Nordisk A/S
Recruiting Phase 3 August 4, 2026
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
NCT07745504 Novo Nordisk A/S
Recruiting Phase 3 August 4, 2026
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
NCT07607587 Novo Nordisk A/S
Recruiting Phase 1 May 29, 2026
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
NCT07564414 Novo Nordisk A/S
Recruiting Phase 3 May 21, 2026
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
NCT07597018 Novo Nordisk A/S
Recruiting Phase 1 May 18, 2026
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
NCT07557953 Novo Nordisk A/S
Recruiting Phase 1 April 30, 2026
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
NCT07527195 Novo Nordisk A/S
Recruiting Phase 1 April 10, 2026
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese
NCT07411560 Novo Nordisk A/S
Recruiting Phase 1 February 9, 2026
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
NCT07253285 Novo Nordisk A/S
Recruiting Phase 3 January 8, 2026
Show 34 more studies
Study Status Phase Start
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
NCT07220759 Novo Nordisk A/S
Active, not recruiting Phase 3 November 5, 2025
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
NCT07220642 Novo Nordisk A/S
Active, not recruiting Phase 3 November 5, 2025
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
NCT07184086 Novo Nordisk A/S
Active, not recruiting Phase 1 September 26, 2025
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
NCT07010432 Novo Nordisk A/S
Recruiting Phase 1 June 12, 2025
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
NCT07011667 Novo Nordisk A/S
Active, not recruiting Phase 3 June 3, 2025
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
NCT06780449 Novo Nordisk A/S
Active, not recruiting Phase 3 February 10, 2025
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
NCT05669755 Novo Nordisk A/S
Active, not recruiting Phase 3 March 1, 2023
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
NCT05567796 Novo Nordisk A/S
Active, not recruiting Phase 3 November 1, 2022
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
NCT07357740 Novo Nordisk A/S
Withdrawn Phase 2 August 27, 2026
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
NCT07357766 Novo Nordisk A/S
Withdrawn Phase 3 June 22, 2026
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
NCT07605052 Novo Nordisk A/S
Completed Phase 1 May 20, 2026
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
NCT06797869 Novo Nordisk A/S
Completed Phase 2 January 29, 2025
A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
NCT06719011 Novo Nordisk A/S
Completed Phase 1 December 3, 2024
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
NCT06716307 Novo Nordisk A/S
Completed Phase 1 December 2, 2024
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
NCT06534411 Novo Nordisk A/S
Completed Phase 3 November 5, 2024
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
NCT06388187 Novo Nordisk A/S
Completed Phase 3 June 24, 2024
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
NCT06409130 Novo Nordisk A/S
Completed Phase 2 May 20, 2024
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
NCT06403761 Novo Nordisk A/S
Completed Phase 1 May 6, 2024
A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
NCT06131372 Novo Nordisk A/S
Completed Phase 2 April 1, 2024
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
NCT06323161 Novo Nordisk A/S
Completed Phase 3 March 26, 2024
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
NCT06323174 Novo Nordisk A/S
Completed Phase 3 March 19, 2024
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
NCT06289504 Novo Nordisk A/S
Completed Phase 1 February 27, 2024
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
NCT06207877 Novo Nordisk A/S
Completed Phase 1 February 23, 2024
A Study of How CagriSema Works on Appetite in People With Excess Body Weight
NCT06267092 Novo Nordisk A/S
Completed Phase 1 February 15, 2024
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
NCT06221969 Novo Nordisk A/S
Completed Phase 3 January 16, 2024
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
NCT06131437 Novo Nordisk A/S
Completed Phase 3 November 27, 2023
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
NCT06065540 Novo Nordisk A/S
Completed Phase 3 September 27, 2023
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
NCT05996848 Novo Nordisk A/S
Completed Phase 3 August 15, 2023
A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants
NCT05804162 Novo Nordisk A/S
Completed Phase 1 April 12, 2023
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
NCT05564104 Novo Nordisk A/S
Completed Phase 1 April 5, 2023
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
NCT05813925 Novo Nordisk A/S
Completed Phase 3 April 3, 2023
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
NCT05394519 Novo Nordisk A/S
Completed Phase 3 February 1, 2023
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
NCT04982575 Novo Nordisk A/S Results posted
Completed Phase 2 August 2, 2021
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
NCT04940078 Novo Nordisk A/S
Completed Phase 1 July 7, 2021

All 44 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
4
Serious
3
With death outcome
0

Most reported reactions

  • Dyspnoea 2
  • Anal incontinence 1
  • Body mass index decreased 1
  • Decreased appetite 1
  • Gastroenteritis 1
  • Illness 1
  • Loss of consciousness 1
  • Nausea 1
  • Product information content complaint 1
  • Pruritus 1
  • Throat tightness 1
  • Thyroid mass 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.